Tildrakizumab for Genital Psoriasis

Recruiting at 13 trial locations

Overseen By Head, Clinical development

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sun Pharmaceutical Industries Limited

Must not be taking: Systemic anti-infectives

Disqualifiers: Erythrodermic psoriasis, Pustular psoriasis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

192 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Tildrakizumab for treating genital psoriasis?

Tildrakizumab has been shown to be effective in treating moderate-to-severe plaque psoriasis, with many patients experiencing significant improvement in their skin condition. In clinical trials, a large number of patients achieved a 75% or greater reduction in their psoriasis severity score, and these improvements were maintained over time. ^{1 2 3 4 5}

Is tildrakizumab safe for humans?

Tildrakizumab has been shown to be generally safe in humans, with clinical trials indicating it is well tolerated and only a slightly higher incidence of nasopharyngitis (common cold symptoms) compared to other treatments. Long-term studies have not raised any significant safety concerns. ^{1 6 7 8 9}

How is the drug Tildrakizumab different from other treatments for genital psoriasis?

Tildrakizumab is unique because it is a monoclonal antibody that specifically targets the p19 subunit of interleukin-23, a protein involved in the immune response that contributes to psoriasis. This targeted approach may offer a more precise treatment option compared to other therapies that do not specifically inhibit this pathway. ^{4 8 9 10 11}

Eligibility Criteria

This trial is for adults over 18 with moderate to severe genital psoriasis, often not well-managed by topical treatments. Participants should have less than 10% body surface area affected by non-genital plaque psoriasis and no active tuberculosis. They must understand the trial's risks, agree to follow its rules, and provide written consent.

Inclusion Criteria

Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines

I am 18 years old or older.

I have moderate to severe genital psoriasis.

Exclusion Criteria

I don't have any health conditions that could make this study unsafe for me.

I am scheduled for surgery before the Week 16 check-up for a condition I had before treatment.

My psoriasis is not mainly plaque type but one of the other forms like erythrodermic or pustular.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous tildrakizumab or placebo for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tildrakizumab

Trial Overview The study tests Tildrakizumab's effectiveness and safety against a placebo in treating genital psoriasis. It's a phase 3 trial where participants receive either the actual drug or a placebo through subcutaneous injections.

Participant Groups

Group I: Tildrakizumab 100 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

Findings from Research

Tildrakizumab demonstrated significant efficacy in treating moderate-to-severe plaque psoriasis, with 62.3% of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12, compared to only 5.6% in the placebo group.

The efficacy of tildrakizumab increased over time, with better responses observed in patients with lower body weight and those receiving the 200 mg dose, indicating that body weight may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28. Papp, KA., Reich, K., Blauvelt, A., et al.[2020]

In a study of 51 patients with moderate-to-severe plaque psoriasis who had previously failed biologic treatments, tildrakizumab showed significant effectiveness, with a marked reduction in the Psoriasis Area Severity Index (PASI) score from 19.2 at baseline to 0.6 at 48 weeks (P < 0.001).

The treatment also led to substantial improvements in Body Surface Area (BSA) and Dermatology Life Quality Index (DLQI) scores, indicating enhanced quality of life for patients, with significant results observed at both 12 and 48 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis. Di Brizzi, EV., Buononato, D., Benvenuto, P., et al.[2023]

Tildrakizumab, a monoclonal antibody targeting IL-23, has shown significant efficacy in treating moderate-to-severe chronic plaque psoriasis, outperforming placebo and etanercept in clinical trials, with effects increasing up to 28 weeks and sustained efficacy for up to 3 years.

The safety profile of tildrakizumab is favorable, with good tolerability and only a slightly higher incidence of nasopharyngitis reported, indicating it is a safe option for patients with psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab: An Evidence-Based Review of Its Use in the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis. Näslund-Koch, C., Zachariae, C., Skov, L.[2020]

In the TRIBUTE study involving 177 adult patients with moderate-to-severe plaque psoriasis, treatment with Tildrakizumab (TIL) 100 mg for 24 weeks resulted in significant improvements in psoriasis severity, with 88.4% of patients achieving a PASI score of ≤3 and 92.5% achieving PASI 75.

The treatment also led to notable enhancements in health-related quality of life, including reduced pruritus, pain, and improved sleep, with a high patient satisfaction score (mean TSQM score of 80.5), and a favorable safety profile with only one serious adverse event reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice. Costanzo, A., Llamas-Velasco, M., Fabbrocini, G., et al.[2023]

In a study of 190 patients with moderate-to-severe plaque psoriasis treated with tildrakizumab for 24 weeks, there was an impressive 88.79% reduction in the Psoriasis Area and Severity Index (PASI), indicating significant effectiveness in managing the condition.

The treatment was found to be safe, with only a 5.9% rate of adverse events, primarily infections, and no significant differences in effectiveness based on factors like gender or prior biological therapy exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of tildrakizumab for the treatment of psoriasis in real-world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group. Berenguer-Ruiz, S., Aparicio-Domínguez, M., Herranz-Pinto, P., et al.[2023]

In a 52-week study involving 237 adults with moderate-to-severe plaque psoriasis, tildrakizumab demonstrated high efficacy, with 90.91% of patients achieving at least a 75% reduction in psoriasis severity (PASI 75) and 58.68% achieving complete skin clearance (PASI 100) by Week 52.

The safety profile of tildrakizumab was favorable, with no significant adverse events reported, and no patients had to discontinue treatment due to side effects, indicating it is a well-tolerated option for psoriasis management in real-life settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis). Narcisi, A., Valenti, M., Gargiulo, L., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Tildrakizumab: A Review in Moderate-to-Severe Plaque Psoriasis. [2019]

3. Austria pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Real-Life Study on the Use of Tildrakizumab in Psoriatic Patients. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of tildrakizumab by patient demographic and disease characteristics across a phase 2b and 2 phase 3 trials in patients with moderate-to-severe chronic plaque psoriasis. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Tildrakizumab: An Evidence-Based Review of Its Use in the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness and Safety of Tildrakizumab in Patients With Moderate-to-Severe Psoriasis: Week 28 Interim Analysis of a Phase 4 Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of tildrakizumab for the treatment of psoriasis in real-world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis). [2023]

11. England pubmed.ncbi.nlm.nih.gov

Treatment of moderate-to-severe plaque psoriasis with tildrakizumab in the real-life setting. [2023]